BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 6307030 · Received February 7, 2017

    Report

    Report Number
    3010536692-2017-00202
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 26, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS SUFFERING FROM HIP PAIN. MR. DUNLOP DECIDED TO REVISE THE CONSERVE BFH AND CUP AND MODULAR NECK. THE PROFEMUR L STEM WAS LEFT IN SITU. A NEW AR8 SHORT NECK WAS IMPLANTED ALONG WITH A DE PUY PINNACLE CUP WITH POLY LINER. MR DUNLOP STATED THAT THE PAIN WAS CAUSED BY WEAR DUE TO SUBLUXATION AND EDGE LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89843 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. X03396409

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention